In a latest press release issued by the Federal agency United States Food and Drug Administration the agency had expanded the approved use of blood thinning drug Xarelto (rivaroxaban) to include treating pulmonary embolism (PE), deep vein thrombosis (DVT) or and to reduce the risk of recurrent DVT and PE following initial treatment. According to reports from the U.S.F.D.A a total of 9,478 patients were recruited in the 3 different clinical trials that were conducted to assess and determine the efficacy and safety of the drug for new indications. In all the subjects patients with PE or DVT were randomly assigned to receive Xarelto, combination of enoxaparin or a placebo.

The decision was taken after the review of the drug under the fast track process “priority review program” that allows FDA to expedite the review process of a drug when no adequate therapy exists to it and /or major advances in the treatment of patients.

According to Richard Pazdur, M.D., director of the office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research the blood thinning drug “Xarelto” is the first oral anti-clotting drug approved to treat reduces the recurrence of blood clots and thrombus. With this move FDA says those patients who are suffering from heart related risk like myocardial infarction would get benefitted and much of the risks could be diminished with the help of this expansion.

Xarelto or also known as rivaroxaban is a blood thinner and anti-coagulant drug that prevents formation of blood clots in the various parts of the body. Generally the formation of blood clots and thrombosis occurs in the lower limb muscles and thigh region which when flow out of the space reaches to the delicate arteries of heart where it could lead to life threatening conditions like myocardial infarction (heart attack).

However at the same time the federal agency FDA has said that drug is reported to have some devastating side effects that need to be addressed. Some of the side effects of the drug includes:

  • Swelling in face
  • Heavy menstrual periods
  • Bleeding through vagina, nose, mouth or rectum
  • Bloody stools
  • Coughing of blood
  • Loss of movements in various parts of the body and joints
  • Itching
  • Muscle pain

Meanwhile various stakeholders like FDA, the drug manufacturer, patients, health professionals have overwhelmingly welcomed the move as the drug is very effective in reducing the rate of formation of blood clots in human body. Most of the myocardial infarction in people of United States are due to these clots and there was a urgent need of medicine that could help people get rid of this and this is what the drug has offered them.